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New injection aims to soothe painful fat lumps

NCT ID NCT06303570

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether CBL-514 injections can reduce pain from lipomas in people with Dercum's disease. Nineteen adults with at least 4 painful lipomas will receive either the drug or a placebo. The main goal is to see if the treatment lowers pain scores.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CBL-514 injection
What this could lead to
If it works, this could point toward a non-surgical treatment to ease pain from Dercum's disease lipomas.
What could go wrong
This is a very small, early phase 2 study with only 19 people. The results may not apply to everyone, and the treatment might not work better than placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

19 people

The number who actually took part.

Started

Nov 2024

Expected to finish

Apr 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 64 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female, aged 18 years to 64 years old (at screening), inclusive. 2. Body mass index (BMI) \>18.5 kg/m2 at screening and Day 1. 3. Has confirmed DD and/or fulfills the following clinical criteria of DD in localized nodular form. The final diagnosis of disease is in the opinion of the Investigator. 1. Chronic pain (\>3 months) in the adipose tissue specific to the presence of lipomas and/or 2. Pain in and around multiple lipomas. 4. Has at least 4 and up to 10 painful and well-defined lipomas with dimension of ≥10 mm and ≤50 mm as measured by ultrasound (read by the Investigator) at screening. 5. Generally considered healthy according to medical history, physical examination, ECG, and laboratory evaluation. 6. Voluntarily signs the informed consent form (ICF) and, in the opinion of the Investigator or designee, is physically and mentally capable of participating in the study, and willing to adhere to study procedures. Exclusion Criteria: 1. Female participant of childbearing potential who is not willing to commit to an acceptable contraceptive regimen from the time of screening and throughout study participation until 90 days after the last IP dose, or who is currently pregnant or lactating. Female participant of childbearing potential who is breastfeeding or anticipates breastfeeding from the time of screening and throughout study participation until 90 days after the last IP dose. Male participant who is not willing to commit to using of a condom and refraining from sperm donation from the time of the first dose of IP, throughout study participation until 90 days after the last IP dose. 2. Unable to tolerate SC injections. 3. Diagnosed with another disorder with similar characteristics as DD as follows. 1. Madelung's disease: multiple symmetric lipomatosis only localized in the upper body ie, shoulders, neck, or head. 2. Panniculitis: inflammation of the SC adipose tissue, characterized by tender nodules and systemic signs. 3. Proteus syndrome: disproportionate and asymmetric overgrowth of skin, and fatty and connective tissue. 4. PTEN hamartoma syndrome: multiple hamartomas which includes segmental overgrowth, lipomatosis, arteriovenous malformation, and epidermal nevus. 5. Gardner syndrome: multiple digestive adenomas with osteomas and multiple skin and soft tissue tumors. 4. Diagnosed with coagulation disorders or is receiving anticoagulant/antiplatelet therapy or medications or dietary supplements, which inhibit coagulation or platelet aggregation. 5. Has fasting glucose concentration \>200 mg/dL, delayed wound healing, bleeding risk, or any diabetic risks which, in the opinion of the Investigator or designee, is inappropriate to participate in the study. 6. Any clinically significant cardiac, hepatic, renal or neurologic/psychiatric disorders that in the opinion of the Investigator places the participant at significant risk, including but not limited to any of the following: 1. Participants with cirrhosis or with inadequate liver function at screening defined as aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, or total bilirubin \>3.0 upper limit of normal (ULN). 2. Participants with renal impairment, defined as both serum creatinine and blood urea nitrogen \>1.5× ULN, or estimated glomerular filtration rate (eGFR) \<90 mL/min/1.73 m2, or who are currently on dialysis. 7. Participant with a history of human immunodeficiency virus (HIV)-1 infection or participant with active HIV infection at screening with positive HIV antigen/antibody (Ag/Ab) combo test. 8. Participant is undergoing chronic steroid or immunosuppressive therapy, with the exception of: 1. Use of oral steroid inhalation indicated for asthma management 2. Use of topical steroid application for skin conditions that are not directly applied to or indirectly affect the treatment area 3. Use of steroid as part of treatment for DD, and no side effects from chornic use. 9. Participant with active or prior history of malignancies within 5 years before screening or currently being evaluated for a possible malignancy, with the exception of adequately treated basal cell carcinoma of skin and in situ squamous cell carcinoma of skin at Investigator's discretion. 10. Abnormal skin, local skin conditions, or body modifications at the treatment area, which in the opinion of the Investigator, is inappropriate for participation in the study, including but not limited to any of the following: 1. Prior wound, scar tissue, or infection in the treated area. 2. Tattoo in the treated area. 11. Use of any analgesic except Cannabis within 2 days prior to Day 1 and use of Cannabis within 14 days prior to Day 1. 12. Requiring continual use of any medication that is known to strongly inhibit or induce CYP1A2 enzymes, sensitive CYP1A2 substrates or drugs with narrow therapeutic index during the study that, in the opinion of the Investigator, may affect the evaluation of the study product or place the participant at undue risk. 13. Participant who has undergone liposuction or aesthetic surgery to the region to be treated before screening or during the study, or aesthetic procedure for body contouring (eg, cryolipolysis, ultrasonic lipolysis, low level laser therapy, lipolysis injection) to the region to be treated within 12 months before screening or during the study. 14. Unable to receive local anesthesia. 15. Known allergies or sensitivities to the study drug or its components. 16. Use of other investigational drug or device within 12 weeks prior to screening.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Investigator Site

    Spokane, Washington, 99204, United States